Telehealth Training for Ostomy Patients

Not currently recruiting at 10 trial locations

Overseen By Mary Wagner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Urban residence, No stoma, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals with ostomies (surgically created openings for waste removal) in better managing their care through telehealth training. The goal is to enhance the quality of life for those who may struggle to attend in-person support due to travel issues or other challenges. Participants will either receive Ostomy Self-Management Training or continue with usual care practices. It is well-suited for cancer survivors with ostomies who live in rural areas and have had their ostomy for at least six weeks. As an unphased trial, it provides a unique opportunity to improve self-care and quality of life through innovative telehealth solutions.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this telehealth training is safe for ostomy patients?

Research has shown that Ostomy Self-Management Training is generally easy for patients to handle. In a study with 93 participants, 80 completed the training without any problems, suggesting that most people find the program manageable. No reports of technology issues arose during the sessions, indicating that the telehealth format works well. Although the study did not specifically mention any negative effects, the high completion rate suggests it is safe. Overall, the evidence indicates that this training is a safe choice for those seeking to improve their ostomy care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telehealth Training for Ostomy Patients because it offers a comprehensive, structured approach to self-management that goes beyond traditional care. Unlike standard ostomy care, which often lacks uniformity and focuses mainly on technical issues, this training empowers patients with essential skills for everyday life. It covers a wide range of topics, including emotional well-being, social interactions, and practical advice for emergencies and travel, providing a holistic support system. This method aims to improve patients' quality of life by fostering independence and confidence in managing their condition.

What evidence suggests that this telehealth training is effective for ostomy patients?

Research has shown that Ostomy Self-Management Training, which participants in this trial may receive, can greatly enhance life for people with ostomies. Studies have found that these programs reduce problems and boost patients' confidence in managing their ostomies. One study discovered that this training led to shorter hospital stays and higher satisfaction for both patients and nurses. Other research indicates that learning through telehealth is as effective as in-person sessions for improving self-care skills. Overall, this training aims to make life more comfortable and improve the quality of life for those adjusting to living with an ostomy. ^{1 3 5 6 7}

Who Is on the Research Team?

Robert Krouse, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adult cancer survivors who've had surgery requiring an ostomy, living in non-urban areas. They must be at least six weeks post-operation, able to complete English questionnaires and training sessions, and consent to the study. A caregiver's support is encouraged but not mandatory.

Inclusion Criteria

There's no limit on how long ago my surgery was.

You must fully understand the study details and sign a form agreeing to participate.

You live in a rural area, far away from the city.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ostomy Self-Management Training

Participants receive training on using pouches and equipment, skincare, ostomy complications, nutritional needs, and other self-management skills via telehealth

12 months

Regular virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after the self-management training

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Ostomy Self-Management Training

Trial Overview The trial tests Ostomy Self-Management Training via telehealth aimed at improving quality of life for rural ostomy patients. It seeks to provide a solution where in-person training isn't feasible due to distance or other barriers.

How Is the Trial Designed?

Group I: Ostomy Self-Management Training Active Control 1 Intervention

Ostomy Self-management Training group in which subject will learn using pouches and equipment, skincare, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for traveling and physical activity recommendations

Group II: Usual care Placebo Group 1 Intervention

Usual care in peri-operative and long-term settings is not standardized for ostomy patients. Usual care does not provide any formal, reproducible training for patients or their caregivers. It typically consists of an Ostomy Care Nurse who works with patients and caregivers concerning technical issues (fitting, emptying, supplies, surrounding skin care, etc.) while the new ostomate is still an inpatient.

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The Ostomy Self-Management Telehealth program (OSMT) showed potential benefits for cancer survivors with urinary tumors, particularly for those who attended more sessions, indicating that engagement in the program may enhance self-efficacy and quality of life.

While the overall results did not show significant improvements compared to usual care, higher attendance at OSMT sessions was linked to better outcomes in self-efficacy, quality of life, and reduced anxiety, suggesting that participation level may influence the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized prospective trial of an ostomy telehealth intervention for cancer survivors. Krouse, RS., Zhang, S., Wendel, CS., et al.[2023]

The Ostomy Self-management Training (OSMT) program is a three-year randomized trial designed to improve health-related quality of life (HRQOL) for cancer survivors with ostomies by enhancing their self-efficacy and activation through telehealth sessions led by trained nurses and peer support.

By integrating goal-setting and problem-solving strategies, the OSMT program aims to address the physical, psychological, social, and spiritual needs of participants, potentially leading to better post-operative care and support for both survivors and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ostomy telehealth for cancer survivors: Design of the Ostomy Self-management Training (OSMT) randomized trial. Sun, V., Ercolano, E., McCorkle, R., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6252251/

Design of the Ostomy Self-Management Training (OSMT ... The study is a three-year, randomized trial that tests the effectiveness of the OSMT program on survivor activation, self-efficacy, and HRQOL. The intervention ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0965206X24000469

Nursing interventions for the self-efficacy of ostomy patients This improvement leads to a reduction in adverse patient outcomes and ostomy complications, shorter hospital stays, and increased patient and nurse satisfaction ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0303015

Telehealth vs in-person education for enhancing self-care of ... Traditional ostomy educational interventions have shown substantial effectiveness on various patient outcomes; likewise, studies on ...

4. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35091

A randomized prospective trial of an ostomy telehealth ... This study compared the Ostomy Self-Management Telehealth program (OSMT) versus attention control usual care (UC).

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05531331

The Effect of Education on Self-Efficacy and Adaptation to ... The aim of this study is to determine the effect of stoma care training given at home via videoconferencing after discharge on the self-efficacy and compliance ...

6. jmir.org jmir.org/2021/9/e26545/

An Ostomy Self-management Telehealth Intervention for ... In total, 3 OSMT sessions were not held owing to non–technology-related reasons. Of the 93 ostomates who participated in OSMT sessions, 80 (86%) ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1876139924000719

Development and Evaluation of a Metric-based Clinical ... It is well-documented that nurses educated in ostomy care positively impact patient safety and quality outcomes, leading to calls for expanded nursing training ...